Phase II study of Vigil® DNA engineered immunotherapy as maintenance in advanced stage ovarian cancer Ovarian Cancer and Us OVARIAN CANCER and US Ovarian Cancer and Us

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Monday, September 26, 2016

Phase II study of Vigil® DNA engineered immunotherapy as maintenance in advanced stage ovarian cancer



abstract
 

Results

Forty-two patients were entered into trial, 31 received Vigil and 11 received standard of care. No ≥ Grade 3 toxicity related to product was observed. A marked induction of circulating activated T-cell population was observed against individual, pre-processed autologous tumor in the Vigil arm as compared to pre-Vigil baseline using IFNγ ELISPOT response (30/31 negative ELISPOT pre Vigil to 31/31 positive ELISPOT post Vigil, median 134 spots). Moreover, in correlation with ELISPOT response, RFS from time of procurement was improved (mean 826 days/median 604 days in the Vigil arm from mean 481 days/median 377 days in the control arm, p = 0.033).

Conclusion

In conjunction with the demonstrated safety, the high rate of induction of T-cell activation and correlation with improvement in RFS justify further Phase II/III assessment of Vigil.

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